CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 515 enrolled
Drug / intervention
Sacituzumab Govitecan-hziy (SG)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01631552
NCT01631552Phase 2Completed
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A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer

Gilead Sciences·interventional·Posted Jun 29, 2012·Updated Aug 12, 2021

In Brief

A Phase 2 clinical trial evaluating Sacituzumab Govitecan-hziy (SG) for Gastric Adenocarcinoma and 15 related conditions. Completed, enrolled 515 participants across 12 sites.

Detailed Summary

The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of sacituzumab govitecan-hziy administered in 21-day treatment cycles at a dose selected in Phase I. Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Adenocarcinoma, Esophageal Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Ovarian Epithelial Cancer, Carcinoma Breast Stage IV, Hormone-refractory Prostate Cancer, Head and Neck Cancers- Squamous Cell, Renal Cell Cancer, Urinary Bladder Neoplasms, Cervical Cancer, Endometrial Cancer, Glioblastoma Multiforme, Triple Negative Breast Cancer, Pancreatic Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2012
Enrollment StartDec 17, 2012
Primary CompletionMar 1, 2019
Study CompletionAug 13, 2020
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 14.0 years ago

Interventions

Sacituzumab Govitecan-hziy (SG)drug

Administered via intravenous (IV) infusion